A NEW STANDARD FOR REDUCING INFECTION IN HIGH-RISK PATIENTS
Bacterial infection is one of the most common causes of cardiac implantable electronic device (CIED) complications, and the standard antibiotic prophylaxis have significant deficiencies when used as a single agent to prevent infection.1-2
The TYRX™ Absorbable Antibacterial Envelope helps reduce infection in high-risk patients and is more effective when combined with the standard treatment.3
Infections are Increasing at a Faster Rate than CIED Implants1
Contributing factors for this increase:
- Older patients receiving devices
- More patient co-morbidities
- Longer procedures
- Changing mix of CIEDs
- Increasing number of pulse generator replacements and upgrades
- Revision Procedures
- More resistant S aureus & coagulase (-) Staphylococcus species (e.g., S epidermidis)
Standard Antibiotic Prophylaxis Is Falling Short
Typically, the same anti-infective measures are used for all patients regardless of their risk of infection.17-18 Pre-operative IV antibiotic prophylaxis is routinely given one hour before first incision. Ninety percent of patients receive cephalosporin and/or vancomycin.
Perioperatively, the tissue pocket is typically irrigated with antibiotic agents.
Approximately 45% of the time, oral antibiotics are prescribed after the procedure. IV antibiotics may be administered for 24 hours after the initial implant.17-18
- Cefazolin and vancomycin can have important clinical limitations when used as a single agent to prevent CIED infection.2
- Coagulase(-) Staphylococcus species and S aureus are responsible for approximately 70% of CIED infections and are increasingly resistant to methicillin.10-16
The TYRX Antibiotic Envelope Offers More Coverage Combined with Standard Treatment3
- Cefazolin and vancomycin are rarely used in combination and have important clinical deficiencies when used as a single agent to prevent CIED infections.2
- Both have activity against gram (+) organisms; there is substantial overlap.2
- Neither has a strong profile against gram (-) organisms.2
- Gentamicin has variable activity against coagulase (-) Staphylococcus, MSSA, and MRSA, and may be effective in some infections, but not reliably effective in others.2
- Topical ionic silver does not have activity against coagulase (-) Staphylococcus and has no data to support coverage in M catarrhalis or Corynebacterium jeikeium.19-22
*
Infection rate is an aggregation of data; see Data on file at Medtronic TYRX.
1
Greenspon A et al. J Am Coll Cardiol. 2011;58(10):1001-1006.
2
The Sanford Guide to Antimicrobial Therapy. Web Edition. 2015: Antimicrobial Therapy Inc.; Hyde Park, VT.
3
Mittal S et al. Heart Rhythm. 2014; 11(4):595-601.
4
Sohail MR et al. PACE. 2015;38(2):231-239.
5
Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services Inpatient Prospective Payment System (IPPS) Final Rule FY13.
6
Bloom HL et al. Pacing Clin Electrophysiol. 2011; 34(2):133-142.
7
Kolek MJ et al. J Cardio Electrophysiol. 2015;26(10):1111-1116.
8
Shariff N et al. J Cardio Electrophysiol. 2015;26(10):783-789.
9
Henrikson CA et al. JACC EP 2017; 3 (10): 1158-1167.
10
Wisplinghoff H et al. CID. 2004;39(3):309-317.
11
NNIS System Report. Am J Infect Control. 2004;32(8):470-485.
12
Klug D et al. Circulation. 2007;116(12):1349-1355.
13
Lekkerkerker JC et al. Heart. 2009;95(9):715-720.
14
de Oliveira JC et al. Circ Arrhyth Electrophysiol. 2009;2(1):29-34.
15
Da Costa A et al. Circulation. 1998;97(18):1791-1795.
16
Chua J et al. Ann Intern Med. 2000;133(8):604-608.
17
MEDACorp. Survey of 42 EPs and 30 cardiac lab supervisors, 2007. Sponsored by TYRX, Inc.
18
Easton Assoc. Survey of 24 EPs, 6 EP lab managers and RNs, 2008. Sponsored by TYRX, Inc.
19
Lansdown A et al. Issues in Toxicology. 2010; 5.3:123.
20
Percival SL et al. Wound Repair Regeneration. 2011; 19(6); 769-770. Online publication.
21
Argentum Medical. Silverlon® Product Brochure.
22
Townsend Letter for Doctors & Patients. April 2006; Issue 273: 66-72.
23
Zinner SH et al. J Infect Dis. 1981;144(4):365-371.
24
Darouiche RO et al. Int J Antimicrob Agents. 1995;6(1):31-36.
25
Segreti J et al. Diagn Microbiol Infect Dis. 1989;12(3):253-255.
TYRX™ Cardiac Absorbable Antibacterial Envelope
*
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScanTM device, see the MRI SureScanTM technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
The envelope is intended to hold the following CIED securely to create a stable environment when implanted in the body at the following locations: Implantable Pulse Generator (IPG), Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Devices (CRT-P and CRT-D); implant locations are pectoral, abdominal, or flank (lateral to the body midline and superior to the gluteal) regions.
The envelope contains the ancillary medicinal substance ansamycin, which has been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the device.
The envelope is contraindicated for use in patients with allergy or history of allergy to tetracyclines, ansamycin, or absorbable sutures; in patients with systemic lupus erythematosus (SLE) because minocycline has been reported to aggravate this condition; in contaminated or infected wounds.